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FDA 510(k)

Access Cortisol; DxC 500i Clinical Analyzer

K-Number: K242190 · 2025-03-05

ApplicantBeckman Coulter, Inc.
Decision Date2025-03-05
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access Cortisol; DxC 500i Clinical Analyzer is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2025-03-05 under approval number K242190. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access Cortisol; DxC 500i Clinical Analyzer?

Access Cortisol; DxC 500i Clinical Analyzer is a medical device that received FDA 510(k) clearance on 2025-03-05. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K242190.

When was Access Cortisol; DxC 500i Clinical Analyzer approved by the FDA?

Access Cortisol; DxC 500i Clinical Analyzer received FDA 510(k) clearance on 2025-03-05, under approval number K242190.

What company makes Access Cortisol; DxC 500i Clinical Analyzer?

Access Cortisol; DxC 500i Clinical Analyzer is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access Cortisol; DxC 500i Clinical Analyzer?

The FDA product code for Access Cortisol; DxC 500i Clinical Analyzer is CGR.

Related Clinical Trials

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Related PubMed Literature

PMID: 41517921 Approval Lag for Ablation Catheters: A Comparative Analysis of Regulatory Timelines in the European Union, United States, and Japan. Journal of cardiovascular electrophysiology (2026) PMID: 40587167 FDA Authorization of Therapeutic Devices Under the Breakthrough Devices Program. JAMA internal medicine (2025) PMID: 39556835 Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters. Annals of internal medicine (2024) PMID: 39374526 Modernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process. Annals of internal medicine (2024)

Other Devices by Beckman Coulter, Inc.

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Related Devices (Code: CGR)

K202136IDS CortisolImmunodiagnostic Systems , Ltd. K202826IMMULITE® 2000 CortisolSiemens Healthcare Diagnostics Products, Ltd. K203270IMMULITE/IMMULITE® 1000 CortisolSiemens Healthcare Diagnostics Products, Ltd. K223038Access CortisolBeckman Coulter, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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